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An Extension Study to Monitor Long-Term Safety of LUM-201 Treatment in Children with Idiopathic Growth Hormone Deficiency
EU CTIS ID: 2023-504020-25-00
What this study is testing
Assess the long-term safety of LUM-201 administration in children with idiopathic growth hormone deficiency (GHD)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Parent/caregiver must sign the informed consent, and the subject must sign the assent, as applicable.
- 2. Must have successfully participated in a pediatric LUM-201 GHD study through at least the 12-month visit, and be eligible for continuation of treatment, pending all other enrollment criteria are met. Specific enrollment criteria for subjects in each LUM-201 trial are listed below. Subjects transitioning from the LUM-201-01 trial will be considered eligible for enrollment pending successful participation in the LUM-201-01 trial, having met an AHV of ≥ 6.7 cm/year after 12 months of LUM-201 therapy. Subjects transitioning from the LUM-201-04 trial will be considered eligible for enrollment pending successful completion of 12 months of therapy with rhGH on the LUM-201-01 trial, followed by 12 months of treatment with LUM-201 in the LUM-201-04 trial and having met an AHV of ≥ 80% of first year growth on rhGH.
- 3. Subjects who are sexually active must use an acceptable form of contraception.
- 4. Is eligible for a Day 1 visit as confirmed by the principal investigator (PI).
You likely can't join if
- 1. Has a medical or genetic condition that, in the opinion of the PI and/or MMs, adds unwarranted risk to use of LUM-201.
- 2. Has planned or is receiving current long-term treatment with medications known to act as substrates, inducers, or inhibitors of the cytochrome system CYP3A4 that metabolizes LUM-201 (see Appendix 1 of protocol for list of example medications). Subjects receiving shorter-term (two weeks or less) treatment with these medications should be evaluated on case-by-case basis by the PI in consultation with the MMs.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Israel
- New Zealand
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Israel; New Zealand; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.